QUETIAPINE FUMARATE

Product NDC: 16729-132
11-digit product format: 167290132
Labeler code: 16729
Product ID: 16729-132_438fdf1f-3027-fb5a-e063-6294a90ac8d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: QUETIAPINE FUMARATE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA206252
Marketing category: ANDA
Marketing start: 2017-11-30
Substance: QUETIAPINE FUMARATE
Active strength: 50 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206252-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2017-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A206252-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206252-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206252-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206252-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206252-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206252-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206252-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206252-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206252-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206252-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206252-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206252-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206252-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206252-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206252-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206252-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206252-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206252-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206252-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206252-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206252-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206252-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206252-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206252-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206252-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206252-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206252-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206252-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206252-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206252-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206252-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206252-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206252-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206252-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206252-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206252-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206252-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206252-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206252-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206252-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206252-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206252-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: QUETIAPINE FUMARATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2S3PL1B6UJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
853201	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
72111c36-c625-434f-9f16-7f25e0ff75f3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ef42f82-f087-0d2c-105f-f791ca69210e	Product name	8	20250729
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
21205abd-8c89-4943-9f85-908f3d4fc3bb	Product name	5	20230501
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-132-10	QUETIAPINE FUMARATE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	8
16729-132-12	QUETIAPINE FUMARATE	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	8
16729-132-17	QUETIAPINE FUMARATE	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-132-12	EA - Each	16729-132	7375be10-07cb-4668-b81d-d73bec691b33	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-132	QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]	7	Current NDC, Legacy NDC, 3 package rows	20240118_72111c36-c625-434f-9f16-7f25e0ff75f3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	72111c36-c625-434f-9f16-7f25e0ff75f3	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206252 application number: ANDA206252 ndc (product): 16729-132

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S3PL1B6UJ	QUETIAPINE FUMARATE	111974-72-2	QUETIAPINE FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
853201	QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet	PSN	72111c36-c625-434f-9f16-7f25e0ff75f3	8
853201	24 HR quetiapine 50 MG Extended Release Oral Tablet	SCD	72111c36-c625-434f-9f16-7f25e0ff75f3	8
853201	quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet	SY	72111c36-c625-434f-9f16-7f25e0ff75f3	8
853201	quetiapine 50 MG 24 HR Extended Release Oral Tablet	SY	72111c36-c625-434f-9f16-7f25e0ff75f3	8
853201	QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet	PSN	00de2262-7070-0988-e063-6294a90a0246	1
853201	24 HR quetiapine 50 MG Extended Release Oral Tablet	SCD	00de2262-7070-0988-e063-6294a90a0246	1
853201	quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet	SY	00de2262-7070-0988-e063-6294a90a0246	1
853201	quetiapine 50 MG 24 HR Extended Release Oral Tablet	SY	00de2262-7070-0988-e063-6294a90a0246	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-132-10	16729013210	30 in 1 BOTTLE					Historical
16729-132-12	16729013212	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-132-12)	2017-11-30	0000-00-00	No	No	Current
16729-132-17	16729013217	1000 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QUETIAPINE FUMARATE	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	8
QUETIAPINE FUMARATE	NuCare Pharmaceuticals,Inc.	2023-07-19	HUMAN PRESCRIPTION DRUG LABEL	1
QUETIAPINE FUMARATE	REMEDYREPACK INC.	2022-01-26	HUMAN PRESCRIPTION DRUG LABEL	4